Lower Extremity Peripheral Arterial Disease and Exercise Ischemia

NCT02041169 | Completed

• 3 other identifiers: 35RC13-9907-CLASH2013-A01381-4413/34-914
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Lower extremity peripheral arterial disease (LEPAD) is a highly prevalent chronic disease. Cardiovascular mortality of LEPAD patients at five years ranges between 18 to 30%. LEPAD is primarily caused by atherosclerosis that induces an inadequate blood flow to meet the tissues demand due to the narrowing of the arteries. An aggravation of the arterial lesions in LEPAD patients induces a worsening of patients' symptoms and a severe limitation of their walking capacity, contributing to an impairment of their quality of life. Despite maintaining a sufficient walking activity is essential for these patients, LEPAD patients lower their physical activity, which worsen the disease and potentially contribute to increase the risk of cardiovascular events and deaths. In a recent study in LEPAD patients, we showed, from a one hour GPS recording, a high variability of the patients' walking capacity (i.e., walking distances between two stops induced by lower limbs pain). Results suggested that in most patients previous stop duration before each walk was a predictor parameter of this walking variability. Whether there is an optimal or minimal recovery time influencing the walking capacity in LEPAD patients has never been studied. This study is a prospective, cross-sectional study in exercise pathophysiology. The main goal is to determine, following a walk that induces ischemia, the influence of the recovery duration on the subsequent walking performance in LEPAD patients. Secondary goals are :

1. 1.To determine the nature of the relationship between the recovery duration and subsequent walking performance.
2. 2.To study the relationship between exercise ischemia, pain evolution and previous recovery duration.
3. 3.To determine whether the experimental procedure influence the determination of an optimal of minimal recovery duration.
4. 4.To study the influence of recovery duration on walking capacity from community-based measurement.

Conditions

Peripheral Arterial Diseases; Intermittent Claudication

Outcome Measures

Primary Outcomes (1)

• Coefficient of determination between the recovery duration and subsequent walking performance, obtained from individual regression analyses.

  Coefficient of determination between the recovery duration and subsequent walking performance, obtained from individual regression analyses.

  32 days

Secondary Outcomes (1)

• Coefficient of determination determined from different curves fitting

  32 days

Other Outcomes (2)

• Coefficient of correlation between the level of ischemia during recovery and exercise ischemia and pain occurrence during subsequent walking

  32 days

• Coefficient of correlation between the optimal recovery duration measured on the laboratory and measures from community-based measurements.

  32 days

Study Arms (1)

Subsequent walking performance

EXPERIMENTAL

Subsequent walking performance

Other: Subsequent walking performance

Interventions

Subsequent walking performance OTHER

Subsequent walking performance

Subsequent walking performance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Insured under the French social security system (according to French law)
• Presence of lower-extremity peripheral artery disease, defined by:
• A resting ankle-brachial index (ABI) ≤ 0.90
• OR if resting ABI \> 0.90 and \< 1.00, a decrease in recovery ankle systolic pressure or in recovery ABI from treadmill exercise higher than 30% or 20%, respectively (AHA recommendations).
• OR if resting ABI \> 1.40, a toe pressure index ≤ 0.70
• Maximal walking distance on treadmill (3.2 km/h, 10% grade) \< 500m (a)
• Complain of exertional lower limbs pain that can begin or not at rest, causes the participant to stop walking and relieves or lessens within 10 minutes of rest (assessed using the San Diego questionnaire AND confirmed during treadmill testing) (b)
• As assessed during the medical appointment.
• i) Intermittent claudication. Patients that experience exertional calf pain that does not begin at rest and that forces them to stop walking and that relieves or lessens within 10 minutes of rest; ii) Atypical exertional leg pain/stop. This category can encompass diverse situations of exertional leg symptoms. In the present study, patients in this category were included if they experience exertional pain that does not begin at rest and that forces them to stop walking, but that do not involve only the calf(s) but also thigh(s) and/or buttock(s). Further, the exertional leg pain relieves or lessens within 10 minutes of rest; iii) Leg pain on exertion and rest. In this category, patients sometimes experience exertional leg pain at rest when they are standing still or sitting. On exertion, patients also experience a walking pain as described above. As reminded by Criqui et al., this category of patients with "pain at rest" should not be confused with patients that experience "rest pain", which usually refers to patients with such severe advanced PAD that ischemic pain is present even at rest. Patients with ischemic rest pain were not included in the study.
• Exercise limitation due to symptoms not related to an arterial insufficiency in the lower limbs (e.g., dyspnea, angina pectoris)
• Contraindication for walking (Abdominal aortic aneurysm \> 4 cm)
• Myocardial infarction and no stroke in the last 3 months
• Critical limb ischemia, amputation.
• Pregnant women

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Rennes University Hospital

Rennes, Brittany Region, 35033, France

Location

Related Publications (4)

• de Mullenheim PY, Chaudru S, Mahe G, Prioux J, Le Faucheur A. Clinical Interest of Ambulatory Assessment of Physical Activity and Walking Capacity in Peripheral Artery Disease. Scand J Med Sci Sports. 2016 Jul;26(7):716-30. doi: 10.1111/sms.12512. Epub 2015 Jul 15.

  PMID: 26173488 RESULT

• Chaudru S, Jehannin P, de Mullenheim PY, Klein H, Jaquinandi V, Mahe G, Le Faucheur A. Using wearable monitors to assess daily walking limitations induced by ischemic pain in peripheral artery disease. Scand J Med Sci Sports. 2019 Nov;29(11):1813-1826. doi: 10.1111/sms.13511. Epub 2019 Jul 31.

  PMID: 31271680 RESULT

• Donnou C, Chaudru S, Stivalet O, Paul E, Charasson M, Selli JM, Mauger C, Chapron A, Le Faucheur A, Jaquinandi V, Mahe G. How to become proficient in performance of the resting ankle-brachial index: Results of the first randomized controlled trial. Vasc Med. 2018 Apr;23(2):109-113. doi: 10.1177/1358863X17740993. Epub 2017 Nov 10.

  PMID: 29125051 RESULT

• de Mullenheim PY, Rouviere L, Emily M, Chaudru S, Kaladji A, Mahe G, Le Faucheur A. "Should I stay or should I go now?" Recovery time effect on walking capacity in symptomatic peripheral artery disease. J Appl Physiol (1985). 2021 Jul 1;131(1):207-219. doi: 10.1152/japplphysiol.00441.2020. Epub 2021 May 13.

  PMID: 33982591 RESULT

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Guillaume MAHE, MD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 20, 2014
• Study Start: September 1, 2014
• Primary Completion: July 1, 2018
• Study Completion: September 1, 2018
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

FR (1)